Urinary incontinence is a control problem of bladder and urethral sphincter, wherein urethral pressure normally exceeds bladder pressure, resulting in involuntary leakage of urine. It can be defined as a syndrome which means more than urination, causing involuntary urination visibly and preventing social activities or sanitation.
Types of urinary incontinence are urge incontinence, stress incontinence, and mixed stress & urge incontinence.
Urge incontinence is caused by instability of detrusor muscle. While feeling the urge to urinate, urge incontinence is involuntarily generated because there is no power to stop and bear the flow of urine.
Stress incontinence comes from increased intra-abdominal pressure, wherein insufficient strength of urethral ligaments, bulbocavernous muscles, transverses perineimuscles and anal sphincters increase intra-abdominal pressure, resulting in leakage of urine, under 50 ml. There are various kinds of reasons for increasing intra-abdominal pressure, such as coughing, sneezing, laughing, bearing down, running, nose blowing, rough exercise, impatience, excited condition, going up stairs quickly, sudden uprising, etc.
Mixed stress & urge incontinence refers to urinary incontinence in combination of urge incontinence and stress incontinence, due to reduction in tensible force of stress incontinence and detrusor muscle.
Generally, urinary incontinence happens to women more than men. The number of employed women is increasing more and more, and aging population is rapidly going up. Therefore, urinary incontinence gives women severe damage in terms of mental, social and economical sides. First of all, as for economical aspects, according to a report in U.S.A. in 1989, expenses for urinary incontinence treatment exceeded $10 billion, larger than those for AIDS treatment. It implies that urinary incontinence causes many economical problems.
As for physical damage, external genitals get wet all the time, resulting in fungal infections and contact dermatitis. As for mental damage, anxiety, tension and shame are due to unpleasant odor, disrupting personal relations and social activities. Also, negative impacts on self concept and self esteem cause mental disorders such as depression or emotional alienation.
Moreover, it has been revealed that the excessive increase of pelvic structure due to pregnancy and delivery weakens contractile force of pelvic floor muscles (vagina muscles), causing erectile dysfunction and urinary incontinence. It was reported that 90 percent of people avoid sexual performance more than once because of urinary incontinence, and more than 80 percent of women with severe symptom keep away from sexual performance. Urinary incontinence is a formidable disease of disrupting marital relation as well as causing inconvenience in daily life.
Urinary incontinence is diagnosed by medical examination by interview, questionnaire, uroflometer, residual urine test, urodynamic study, cystoscopy, radiographic and ultrasonic inspection, micturition chart, pad inspection, perineometer, etc. Among them, the perineometer, foreign-made, is divided into manual (pump) operation and automatic operation, and measures symptoms of urinary incontinence and effects of exercise for strengthening pelvic floor muscles (Kegel exercise) by measuring contraction pressure and duration of pelvic floor muscles in hospitals and research facilities in colleges. However, it is the problem that the perineometer needs professional knowledge. Thus, it is difficult for people to operate the perineometer.
Urinary incontinence is cured by medications, surgery, nonsurgical method, etc. Medications include anticholinergic drugs, smooth muscle relaxants, tricyclic antidepressant, etc. And, types of surgery are Sling operation, Burch operation, TVT (Tension-free vaginal tape), collagen injection, balloon treatment, etc.
There are physiotherapy and behavior therapy in nonsurgical treatments. Physiotherapy has electrical stimulation, transcranial magnetic stimulation, vaginal cone, hyperthermia, magnetic stimulation, perineometer feedback, etc.
Among them, the electrical stimulation refers to a method for inducing passive muscle strengthening by applying electrical stimulation to pelvic floor muscles; and the transcranial magnetic stimulation refers to a method for passively contracting pelvic floor muscles with magnetic field. Behavior therapy refers to bladder training, Kegel exercise, biofeedback, etc.
Bladder training means manual expression of bladder urine on time. Kegel exercise indicates pelvic muscle training designed by Arnold Kegel in 1948, widely used in curing urinary incontinence and muscles by improving functions and strengthening of muscles throughout contraction of pelvic floor muscles. Since pelvic floor muscles (vagina muscles) are not often used, it is important to exercise muscles in the right way. When exercising pelvic floor muscles, abdominal or hip muscles besides pelvic muscles may be used and then, this causes increased abdominal pressure and worse urinary incontinence.
Biofeedback refers to physiological self regulation, which is one of behavior treatment based on learning through reinforcement, suggested by B. F. Skinner, wherein a patient realizes what he sees, hears and feels himself by detecting his physiological responses and converting them into visual, auditory and sensible signals.
In addition, erectile dysfunction is divided into symptoms of female and male. There are sexual desire disorder, sexual arousal disorder, orgasmic disorder and dyspareunia in female erectile dysfunction.
In addition, there are premature ejaculation, impotence, painful ejaculation, prostatic disease and hyposexuality in male erectile dysfunction.
First, premature ejaculation, one of male erectile dysfunction, has no medically certain definition, but it is defined that 50 percent of total sexual intercourse occurs when a man can not control ejaculation and expels semen soon before a female partner feels satisfaction. Generally, 40 percent of adult men have this symptom. Premature ejaculation is a prevalent sexual dysfunction in men, accounting for 60˜70 percent of patients who visit urological department. Although there may be statistical differences, it often occurs among high educational people and city dwellers. Recently, it is rapidly increasing among the young.
The main reason for premature ejaculation may have been considered as mental problems, but the exact reason has not been disclosed. Mental conflicts, worries, early sex activity, coitus interrupts by concern for pregnancy, masturbation, and abnormal feeling of glans may be the reasons. These can be diagnosed by self approach to sexual function, behavioral approach, psychological approach, medical examination by interview, physical examination, biothesiometry, penile color Doppler ultrasound, Rigiscan and ejaculatory duct sensitivity test.
The treatments of premature ejaculation are behavior therapy, medications, local application method, self injection for blood vessel expansion, penile dorsal neurectomy, autogenous dermis graft, transcranial magnetic stimulation of inside and outside of body, anal sphincters biofeedback therapy, oriental medicine and oriental suppository.
Next, impotence is defined as inability to develop or maintain an erection of the penis during sexual performance. 52 percent of adult men, over 40s, suffer from this symptom. The reasons are mental problems, aging, diseases, drug side effects, alcohol and smoking.
Impotence is diagnosed by medical history, medical examination by interview, International Index of Erectile Function (IIEF), physical examination, hormone examination, penile erection induction reaction test, transrectal ultrasonography, penile color Doppler ultrasound, dynamic infusion cavernosometry and cavernosography, penile arteriography, Rigiscan, snap gauge, visual stimulation examination and electromyography. Also, the treatments of impotence include psychiatric therapy, medications, penile vascular surgery, penile vascular reconstructive surgery, penile vein ligation for venogenic impotence, penile prosthesis, self injection for blood vessel expansion, penile vacuum constriction device, transcranial magnetic stimulation of inside and outside of body, anal sphincters biofeedback therapy, oriental medicine and oriental suppository.
Next, there is sexual disorder which comes from prostatic disease.
Located at the bottom face of bladder between pubic bones and rectum, prostate is fixed to bladder neck, on the top, urogenital diaphoretic, at the low side, and puboprostatic ligament in front, and is deeply situated in pelvic cavity. It is an approximately 20-gram chestnut-shaped organ surrounding posterior urethra in a form of wheels, and is a sex organ only existed in males. Urethra is obliquely penetrating toward the front side of the prostate. Also, both ejaculatory ducts are passing through parenchyma at the back of the urethra. Divided into three glandular lobes, the parenchyma of the prostate is composed of tract vesicular structures whose types are glandular tissue and interstitium, wherein a middle lobe is upper than a penetrated part of the ejaculatory ducts and a side lobe is in the right and left of the urethra. In addition, the prostate provides sperm in testicle with nutrition by producing 30 percent of semen and helps fertility of sperm throughout liquefying ejaculated semen and reinforcing sperm motility. Also, alkaline prostatic fluid has an important role in sperm, namely, helping sperm to reach to oviduct for fertilization throughout neutralizing the inside of strong acid vagina.
Meanwhile, diseases related to the prostate are classified into prostatitis, prostatomegaly and prostate cancer. Among prostate diseases, prostatitis mostly occurs in Koreans more than Westerners and the frequency of prostate cancer is relatively low. However, the frequency of prostatomegaly and prostate cancer has been gradually increased due to western lifestyle and the increase of aging population.
First, prostatitis is inflammation of the prostate. 30 percent of men in their 20s to 50s suffer from the prostatitis; 50 percent of men experience once in their lives; and this is the most common disease that 25 percent of patients who visit urological department suffer from. There are acute and chronic bacterial prostatitis, chronic noninfectious prostatitis and prostatodynia.
Symptoms of prostatitis are micturition disorders, such as residual urine, urinary frequency, nocturia, pyuria and narrow voiding stream, and male erectile dysfunctions, such as unpleasant feeling and pain in lower abdomen and perineum, backache, didymalgia, dysuria, whole muscle pain, painful ejaculation, premature ejaculation and impotence.
Further, prostatitis is diagnosed by papation test, inflammatory cell test, bacterial culture, uroflowmetry test, cystoscope test, prostate ultrasonography, color Doppler ultrasound, and polymerase chain reaction (PCR) test. Treatments of prostatitis include special antibiotics, anticholinergic drugs, alpha blocker, hormone drugs, skeletal muscle relaxants, medicine injection into prostate, neurodepressive therapy, microwave thermotherapy, sacral nerve stimulation, transurethral needle ablation (TUNA), oriental medicine, oriental suppository, anti-inflammatory analgesic drug, prostate massage, sitz bath in warm water, thermal massage, low frequency electrical stimulation, transcranial magnetic stimulation of inside and outside of body, biofeedback exercise, pelvic exercise and diet therapy.
However, prostatitis is considered as a chronic disease because it is often hard to find out causative organisms and reasons for prostatitis; there is a limit (about 60 percent, cured) to cure with medicine due to no medicinal penetration of prostate, consisting of special cells; and it is frequently recurred even after symptoms are alleviated. Accordingly, since many patients long for treatment in various ways, not only the efficiency of occupation is declined due to physical, economical and mental exhaustion, but the quality of life is remarkably endangered.
Next, prostatic hypertrophy, most common in prostate of men after middle age, is a disease which causes defecation disorders and erectile dysfunction. It is occurred by multiplying epitheliums, smooth muscles and connective tissue of prostate in terms of histology, and urinary tract is pressurized by enlarged prostate and uroflow resistance in terms of functions. Also, genetic factors, physical constitution, nutrition, artery hardening and differences among human races are considered as the causes of prostatic hypertrophy, but these have not been correctly revealed. Given high frequency among old people, it is closely related to male hormones.
Treatments of prostatic hypertrophy include medical history, International Prostate Symptoms Score (I-PSS), digital rectal examination, uroflometer, residual urine test, transrectal ultrasonography, tissue inspection, prostate specific antigen (PSA), bladder scan, urine examination, tissue inspection and renal function test. Symptoms of prostatic hypertrophy are defecation disorders, such as urinary frequency, nycturia, hesistancy, pyuria, residual urine and retention of urine, and male erectile dysfunctions, such as unpleasant feeling and pain in lower abdomen and perineum, backache, didymalgia, dysuria, whole muscle pain, painful ejaculation, premature ejaculation and impotence. Treatments of prostatic hypertrophy are classified into watchful waiting, medical treatment, physical treatment, minimaly invasive therapy, and surgical treatment: there are alpha-adrenergic antagonists, Finasteride, anti-androgens, oriental medicine and oriental suppository in medical treatment; there are biofeedback therapy, low frequency electrical stimulation and transcranial magnetic stimulation of inside and outside of body in physical treatment; there are ballon dilatation, prostate stents, thermotherapy (TUMT), TULIP, VLAP, TUEP, KTP, high intensity focused ultrasound (HIFU), transurethral needle ablation (TUNA), laser prostatectomy, electro vaporization and thermal therapy in minimaly invasive therapy; and there are transurethral resection of prostate (TURP), transurethral incision of prostate (TUIP) and open prostatectomy in surgical treatment.
Next, prostatic carcinoma refers to a malignant tumor which starts from surrounding areas of prostate. It frequently occurs as long as people get older: men over 50 mostly develop prostatic carcinoma. It is a quite common disease in Westerners, especially in men, and prostatic carcinoma is the second highest death rates after lung cancer. The frequency of prostatic carcinoma in Korean men is lower than that of Westerners, but aging population is steadily increasing due to Westernized food style, air pollution, environment pollution, etc.
In addition, it is reported that genetic factors, age and male hormones are assumed as the causes of prostatic carcinoma even though these causes seem uncertain. Prostatic carcinoma starts gradually, thus unrecognized. At first, unpleasant feeling and pain in perineal region and rectum occur. Then, defecation disorders, hematuria, pyuria, and renal dysfunction are shown gradually. Metastasis mostly occurs in bones. Prostatic carcinoma is accidentally found during annual medical checkup or prostate hypertrophy examination rather than a patient or a doctor's concern and conscious symptoms.
Prostatic carcinoma is diagnosed by Digital Rectal Examination (DRE), transrectal ultrasonography, tissue examination, Prostate Specific Antigen (PSA) test, perineal punch biopsy, bone scan, and lymphangiography. Treatments of prostatic carcinoma include hormonal therapy for medicating antiandrogen or female hormones; surgical therapy for performing radical prostatectomy; radio therapy for applying radiation to external affected prostate; and Chemo therapy for medicating more than two anticancer drugs when hormone therapy is not valid. The prognosis of prostatic carcinoma depends on physical condition, age, and character (differentiated degree) of cancer cells. Generally, the progress of prostatic carcinoma is slow. Thus, five year survival rates are 70˜90 percent when cancer is limited to prostate; 50˜70 percent when cancer spreads to the surroundings of prostate; 30˜50 percent when cancer spreads to lymph node; and 20˜30 percent for remote metastasis to bones or lung. Also, five year survival rates are 85˜95 percent for radical prostatectomy.
Meanwhile, brief explanations on “hemorrhoids (haemorrhoids)”, “fecal incontinence”, and “constipation”, which are major symptoms of defecation disorders, are as follows.
First, most of adult suffer from hemorrhoids, which is a disease occurring in the bottom of rectum, anus, and tissue of the surrounding of anus. Types include haemorrhoids, anal fistula, anal fissure, anusitis, pruritus ani, and rectal prolapse.
Among them, “haemorrhoids”, which accounts for 50 percent and is mostly recognized as hemorrhoids, is a disease in which interior blood vessels of anus are expanded for some reasons, thus making anal mucosal surfaces, which cover the blood vessels, abnormally enlarged or stretched and even protruded outside the anus in severe cases. 40˜50 percent of adult men and women suffer from haemorrhoids. It is classified into internal hemorrhoids (20 percent), external hemorrhoids (10 percent) and mixed hemorrhoids in accordance with shapes and positions, and it is generated by aging, genetic factors, abnormal defecation habit such as constipation and diarrhea, wrong food life like eating meat and drinking alcohol, overwork, physical fatigue, hepatocirrhosis, tumors in abdominal cavity, and pregnancy. Types of diagnosis include medical examination by interview, inspection, Digital Rectal Examination (DRE), proctoscope, sigmoidoscopy, anorectal ultrasonography, anorectal manometry, and anal electromyography.
Treatments of hemorrhoids are diet therapy, exercise, sitz bath in warm water, massage, ointment, suppository, thermal therapy, oriental medicine, oriental suppository, biofeedback therapy, injection, elastic ring ligature, infrared heat photocoagulation, cryotherapy, laser treatment, and surgery.
Next, fecal incontinence means excretion of gas or liquid excrement in unconscious state. This is not a disease, but a symptom which influences patients' lives by causing severe mental anguish. It occurs for various reasons of damage of pelvic muscles, anal sphincters, central nerves and pudendal nerves, sense malfunction of rectum, dysfunction of anal sphincters, congenital malformation, childbirth, and long-time use of obstruent. Fecal incontinence is diagnosed by physical examination by interview, anorectal manometry, anal electromyography, defecography, and anal ultrasonography. Also, it is cured by diet therapy, medications, gastrocolic reflex, biofeedback therapy for rectum and anal sphincters, anal sphincters repair, and postanal redressement.
Next, constipation, a major symptom of defecation disorders, refers to a situation that the number of defecation is less than twice a week; the weigh of bowel movements is below 35 g a day; 25 percent from the total bowel movements go for hard stool or sensation of incomplete evacuation; and more than two symptoms among the above situations continue over 3 months. Frequency is about 10 percent of the total population: especially, the frequency of young women and old people is approximately three times higher than that of men or young people. Causes include: mental or environmental factors (stress), wrong food style, dyscrinism, disturbances of metabolism, nerve disorder, drug abuse, and constitutional abnormality of large intestine or anus. Constipation is diagnosed by digital rectal examination, colonoscopy, colonic transit time, large bowel study, endoanal ultrasonography, anal sphincters electromyography, and anal manometry. It is treated with bowel movements training, intake of dietary fiber and lactic acid bacteria, change of living habits, medications, oriental medicine, oriental suppository, biofeedback therapy for rectum and anal sphincters, low frequency electrical stimulation, transcranial magnetic stimulation of inside and outside of body, and surgery. Among these methods, “biofeedback therapy” refers to contraction and relaxation therapy which is now significantly effective in constipation and fecal incontinence. It treats symptoms by doing exercise in person while checking status of contraction and relaxation of one's rectum and anal sphincters through probe, LCD display and headphones, and strengthening functions of declined sense of rectum and sphincters with maximized capacity of somatic nerves, autonomic nerves and sensory motor neuron. This is the most fundamental and effective treatment among methods for curing constipation and fecal incontinence.
Explanations on causes, symptoms and treatments of urinary incontinence, erectile dysfunction, prostatic disease and defecation disorders are described as above. General explanations on biofeedback exercise and practical use are as follows.
Anorectal physiology examination of pelvic floor muscles (vagina muscles), muscles of perineum, and anal sphincters is a means for diagnosing urinary incontinence, erectile dysfunction, prostatic disease and defecation disorders: types include anorectal manometry, balloon expulsion test, balloon proctography, defecography, colonic transit time study, anal electromyography, transcrectal ultrasonography, anorectal angle, and saline continence test.
Further, among these types, the anorectal manometry is equipped with both physiologic test for rectum and anal sphincters and biofeedback therapy, widely used in hospitals in relation to large intestine and anus diseases.
In addition, biofeedback, a compound word of biology and feedback, refers to physiological self regulation, which is one of behavior treatment based on learning through reinforcement, suggested by B. F. Skinner, wherein a patient realizes what he sees, hears and feels himself by detecting his physiological responses and converting them into visual, auditory and sensible signals. Recently, it belongs to one of orthodox medicine across alternative medicine and complementary medicine, and it is widely utilized in curing more than about 150 symptoms. Biofeedback exercise is applied in pelvic floor muscle biofeedback exercise used in incontinence treatment, vagina muscle and anal sphincters biofeedback exercise used in erectile dysfunction treatment, rectum and anal sphincters biofeedback exercise used in irritable bowel syndrome, constipation, and fecal incontinence, frontal muscle electromyelogram (EMG) biofeedback exercise used in control of brainwave, electro cardiogram biofeedback exercise used in high blood pressure and arrhythmia treatment, body temperature biofeedback exercise, and Galvanic skin response biofeedback exercise.
As stated above, besides a means for diagnosing and curing urinary incontinence, erectile dysfunction, prostatic disease and defecation disorders, there are apparatus, currently used or granted for patent (utility model), such as a pole-shaped anus injecting apparatus using very low frequency (VLF), ultrasound, infrared ray, near infrared (NIR), laser, heat, warm water, vibration, and vacuum, urethra injection catheter using ultrasound, perineum massaging apparatus using vibration, heat, and low frequency, warm-water bath, sitz bath in warm water, and hot mugwort pipe shape using oriental medicine like mugwort.
However, such apparatuses just temporarily alleviate pain or unpleasant feeling. Also, the effect of treatment works in the short term, thus not satisfying users.
Furthermore, oral medication, used for treatment, has problems of side effects, like drug tolerance, organic malfunction and organic damage due to long-term drug taking, and should combine surgery because only medication can not completely cure diseases. As for western suppository and oriental suppository, effects do not last long. Not only is it very unhealthy because of finger-using injection into rectum and anus, but patients should live with long-time injection. Nevertheless, medications can not be fully absorbed into human body.
Also, anorectal manometry makes up the majority of physiologic test and biofeedback treatment for anal diseases, defecation disorders and erectile dysfunction and is used in most of hospitals. However, patients should visit hospital many times, and it is too complex to operate for users. Also, it is quite expensive and therefore, it costs a lot for inspection and treatment.
Furthermore, widely used in urinary incontinence and defecation disorders, low frequency electrical stimulation and transcranial magnetic stimulation of inside and outside of body use current and magnetic field, thus making contraction and relaxation of muscles move. Treatment effects are short; it may be recurred; and scientific reproducibility is not enough.
In addition, as for antibiotics widely used in prostate and anal diseases, there have been resistant bacteria which can not be cured by existing antibiotics: these have been incurred by misuse and overdose in advanced countries, and drug tolerance by small dose, below adequate amount, in developing countries. Thus, the World is currently facing to a serious level. Actually, in U.S.A., medical expenses for antibiotic tolerance amount for about $30 billion per year. In Korea, antibiotics consumption is about 33.2 people for every 1,000 people a day. It is 1.5 times higher than OECD (Organization of Economic Corporation and Development)'s average of 21.3 people. Also, the rate of prescription for antibiotics in hospitals is 58.9 percent, more than 2˜3 times exceedingly higher than WHO (World Health Organization)'s recommended value of 22.7 percent; and the rate of prescription for injections amounts to 56.6 percent, even 3 times higher than WHO's recommended value of 17.2 percent. Especially, the resistant rate of penicillin for staphylococcus is 95 percent and thus, the rate of antibiotics misuse in Korea is the world's highest. The number of antibiotics resistant patients is on the increase, and efforts to stop this situation are just temporary solutions. Thus, now, there is no any special way.
Further, as for a personal apparatus for diagnosis and treatment using silicon air probe (Korean Patent nos. 10-0710908, 10-0727783), filed by the applicant of the present invention and granted for patent, a diagnosis and treatment apparatus for hospitals has a problem that a patient, who goes to a hospital for the first time, must inject an air probe into his coelom by nurse's assistance at a partially open place, thus causing inconvenience and shame, although it is rare for most of users to feel shame and inconvenience because of home use.